Label

The written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.

Reference: MDR Article 2(13); IVDR Article 2(13)

Legacy device

A device CE marked under the Medical Device Directive 93/42/EEC or the Active Implantable Medical Devices Directive 90/385/EEC and placed on the market under the MDR transitional arrangements. Not an MDR term: it comes from guidance, and it governs what level of clinical evidence is expected during transition.

Reference: MDCG 2020-6

Making available on the market

Any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. Under the IVDR: any supply of a device, other than a device for performance study, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

Reference: MDR Article 2(27); IVDR Article 2(20)

Manufacturer

A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

Reference: MDR Article 2(30); IVDR Article 2(23)

Market surveillance

The activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection. Under the IVDR: the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.

Reference: MDR Article 2(61); IVDR Article 2(64)

MCID — Minimal clinically important difference

The smallest change in an outcome measure that a patient would perceive as meaningful. Used when setting clinical benefit and outcome parameters, so that statistically significant results are not mistaken for clinically relevant ones. A clinical research concept, not a regulatory definition.

MDCG — Medical Device Coordination Group

The group of Member State experts that advises and assists the Commission, issues guidance on the application of both regulations, and contributes to notified body designation and scrutiny. Its guidance documents are not legally binding.

Reference: MDR Article 103

MDD — Medical Devices Directive 93/42/EEC

The directive that governed most medical devices in the EU before the MDR, repealed by the MDR subject to transitional provisions. Devices certified under it are referred to in guidance as legacy devices.

Reference: MDR Article 122

MDSW — Medical device software

Software intended to be used, alone or in combination, for a medical purpose as set out in the definition of a medical device. Guidance distinguishes software that drives or influences a hardware device from software with an independent medical purpose, which is a device in its own right.

Reference: MDCG 2019-11

MEDDEV — MEDDEV guidance

The series of European consensus guidance documents produced under the directives, of which MEDDEV 2.7/1 revision 4 on clinical evaluation is the most used. Not legally binding and not written for the MDR, but still referenced in practice where MDCG guidance has not replaced it.

Medical device

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. (1) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24). Under the IVDR: ‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745.

Reference: MDR Article 2(1); IVDR Article 2(1)

MIR — Manufacturer incident report

The standard form used to report a serious incident to a competent authority under the vigilance system. The form and its coding are set out in Commission guidance rather than in the regulation itself, which specifies the reporting deadlines and the content required.

Reference: MDR Article 87; IVDR Article 82

NANDO — New Approach Notified and Designated Organisations

The Commission database listing notified bodies and the scope each is designated for. A designation takes effect the day after the notification is published there, so it is the authoritative source for checking whether a body may lawfully assess a given device type.

Reference: MDR Article 42; IVDR Article 38

Nanomaterial

A natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials.

Reference: MDR Article 2(18)

Non-viable

Having no potential for metabolism or multiplication.

Reference: MDR Article 2(16)

Notified body

A conformity assessment body designated in accordance with this Regulation.

Reference: MDR Article 2(42); IVDR Article 2(34)

OBL — Own brand labelling

Placing another company’s device on the market under your own name or trade mark. Doing so makes you the manufacturer with all the accompanying obligations, unless there is an agreement under which the actual manufacturer is identified on the label and remains responsible.

Reference: MDR Article 16(1)(a); IVDR Article 16(1)(a)

Orphan device

A device specifically intended to benefit patients with a disease or condition presenting in no more than 12,000 individuals in the EU per year, where there is an insufficiency of available alternatives or where clinical data cannot reasonably be generated in the usual way. A guidance concept affecting the clinical evidence expected.

Reference: MDCG 2024-10

Packaging levels

The various levels of device packaging that contain a defined quantity of devices, such as a carton or case.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Particle

For the purposes of the definition of nanomaterial in point (18), a minute piece of matter with defined physical boundaries.

Reference: MDR Article 2(19)